Education and Training
A Phase 2 Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease
The addition of rituximab to prednisone for the initial treatment of chronic GVHD will increase the overall response rate, enable a more rapid and effective steroid taper.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Rituximab
- drug: Prednisone
- drug: cyclosporine A
- drug: tacrolimus
Eligibility
Inclusion Criteria:
- Children and adults with a new diagnosis of chronic GVHD- that requires systemic
immunosuppressive treatment to a dose of 1mg/kg/day prednisone and who have undergone
any type of donor hematopoietic cell graft or conditioning regimen.
- Stable doses of other immunosuppressive medications (e.g. calcineurin inhibitors,
mycophenolate mofetil) for 2 weeks prior to enrollment. In addition, these other
immunosuppressive medications should not be dose increased.
- Men and women of reproductive potential must agree to use an acceptable method of
birth control during treatment and for six months after completion of treatment.
- All subjects must provide written informed consent.
Exclusion Criteria:
- Known life-threatening hypersensitivity to Rituximab or other anti-B cell antibody.
- Treatment with prednisone (or equivalent) at doses higher than 1 mg/kg/day at the time
of enrollment. Persistent prednisone treatment of acute GVHD that is less than 1mg/kg
is allowed.
- Active, uncontrolled infection- CMV reactivation is excluded (i.e. pneumonitis,
colitis). Peripheral blood CMV reactivation is allowed as long as it is not associated
with CMV disease and is responding to therapy.
- Known Hepatitis B surface Ag positive
- Active malignant disease relapse.
- Pregnancy
- Lactating
- Inability to comply with the Rituximab treatment regimen.
Ages Eligible for Study
1 Year - 75 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
BMT Referrals
6507230822
Not Recruiting